14 research outputs found
The influence of antioxidants on the genotoxicity of chemical mutagens detected with the SOS chromotest
0155 ICE study: Ibandronate with or without capecitabine in elderly patients with early breast cancer
Topotecan (T) +/- Sorafenib (S) for platinum-resistant ovarian cancer (PROC): results of doubleblind placebo-controlled randomized NOGGO - AGO intergroup trial
De-escalated neoadjuvant T-DM1 with or without endocrine therapy (ET) vs trastuzumab plus ET in early HR+/HER2+breast cancer (BC): ADAPT-TP survival results
Final analysis of WSG-ADAPT HER2+/HR+ phase-II-trial - efficacy, safety and predictive markers for 12-weeks of neoadjuvant T-DM1 with or without endocrine therapy versus Trastuzumab plus endocrine therapy in HER2-positive hormone-receptor-positive early breast cancer
The role of immune and apoptosis markers for prediction of pCR in the WSG-ADAPT HER2+/HR+ phase II trial evaluating 12-weeks of neoadjuvant TDM1 +/- endocrine therapy (ET) versus T + ET in HER2-positive hormone-receptor-positive early breast cancer (EBC)
De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab +/- weekly paclitaxel
Response rates in HER2-overexpressing EBC treated with neoadjuvant chemotherapy and trastuzumab (T) have been improved by addition of pertuzumab (P). The prospective, phase II, neoadjuvant WSG-ADAPT HER2+/HR- trial assessed whether patients with strong early response to dual blockade alone might achieve pathological complete response (pCR) comparable to that of patients receiving dual blockade and chemotherapy. Female patients with HER2+/HR- EBC (M0) were randomized (5:2) to 12 weeks of T + P +/- weekly paclitaxel (pac) at 80 mg/m(2). Early response was defined as proliferation decrease a parts per thousand30% of Ki-67 (versus baseline) or low cellularity (< 500 invasive tumor cells) in the 3-week biopsy. The trial was designed to test non-inferiority for pCR in early responding patients of the T + P arm versus all chemotherapy-treated patients. From February 2014 to December 2015, 160 patients were screened, 92 were randomized to T + P and 42 to T + P+pac. Baseline characteristics were well balanced (median age 54 versus 51.5 years, cT2 51.1 versus 52.4%, cN0 54.3 versus 61.9%); 91.3% of patients completed T + P per protocol and 92.9% T + P+pac. The pCR rate in the T + P+pac arm was 90.5%, compared with 36.3% in the T + P arm as a whole. In the T + P arm, 24/92 were classified as non-responders, and their pCR rate was only 8.3% compared with 44.7% in responders (38/92) and 42.9% in patients with unclassified early response (30/92). No new safety signals were observed in the study population. Addition of taxane monotherapy to dual HER2 blockade in a 12-week neoadjuvant setting substantially increases pCR rates in HER2+/HR- EBC compared with dual blockade alone, even within early responders to dual blockade. Early non-response under dual blockade strongly predicts failure to achieve pCR